Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)

Part of paid clinical trials in Miami, Florida.

Sponsor
Gilead Sciences
Study ID
NCT06562907
Phase
PHASE1
Status
Recruiting
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Conditions

  • Weight Management

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • GS-4571 — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally
  • Omeprazole — DRUG
    Administered orally

Study Details

The goal of this clinical study is to learn more about the study drug, GS-4571, and how safe it is in 3 groups, i) Healthy participants, ii) Healthy non-diabetic obese participants, and iii) Non-obese participants with Type 2 Diabetes Mellitus (T2DM). The primary objectives of this study are: * To characterize the pharmacokinetics (PK) of GS-4571 following single and multiple ascending oral doses of GS-4571. * To evaluate the effect of concomitant food intake and (if conducted) a representative acid-reducing agent (proton pump inhibitor (PPI), omeprazole) on the PK of GS-4571. * To evaluate the safety and tolerability of single and multiple ascending oral doses of GS-4571.

Key Dates

Start date
Aug 28, 2024
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A Single-ascending Dose (SAD) in Healthy Participants
    Participants will be randomized into 4 + (optional) 1 dose escalating cohorts and will receive GS-4571 or placebo to match (PTM) GS-4571 on Day 1, to determine the maximum tolerated dose: * Cohort 1: Dose 1 GS-4571, administered orally as a single dose, in a fasting state. * Cohort 2: Dose 2 GS-4571, administered orally as a single dose, in a fasting state. * Cohort 3: Dose 3 GS-4571, administered orally as a single dose, in a fasting state. * Cohort 4: Dose 4 GS-4571, administered orally as a single dose, in a fasting state. * Cohort 5 (optional): Dose 5 GS-4571, administered orally as a single dose, in a fasting state.
  • Experimental: Part B Food/PPI Effect in Healthy Participants
    Participants will be randomized into 2 sequence groups in Cohort 6 and will receive the highest dose found to be safe and well tolerated in Part A of GS-4571 and omeprazole. The two sequential groups will receive the following treatments: * Treatment A: Up to the highest single dose of GS-4571 evaluated in Part A, fasting. * Treatment B: Up to the highest single dose of GS-4571 evaluated in Part A, nonfasting (high-fat/high-calorie meal). * Treatment C (optional): Omeprazole, once-daily (QD) for 5 days, fasting. * Treatment D (optional): Omeprazole followed by up to the highest single dose of GS-4571 evaluated in Part A, 2 hours later, fasting.
  • Experimental: Part C Multiple-ascending Dose (MAD) in Nondiabetic Obese Participants
    Participants randomized in Cohorts 7-9 will be randomized to receive up to 4 escalating doses of GS-4571 or PTM QD for 12 weeks, as follows: * Cohort 7: Up to dose determined from Part A of GS-4571 or PTM in obese participants, QD, in a non-fasting state * Cohort 8: Up to 3-fold the Cohort 7 dose of GS-4571 or PTM in obese participants, QD, in a non-fasting state * Cohort 9: Up to 2-fold the Cohort 8 dose of GS-4571 or PTM in obese participants, QD, in a non-fasting state * Cohort 10 is optional and will receive GS-4571 or PTM QD for 12 weeks in case it is opened for enrollment as follows: * Up to 2-fold the Cohort 9 dose of GS-4571 or PTM in obese participants, QD, in a non-fasting state.
  • Experimental: Part D Multiple Dose in Nonobese Participants With T2DM
    Participants randomized in Cohort 11 will receive up to the highest dose of GS-4571 or PTM in T2DM, QD, in a non-fasting state for 12 weeks.

Primary Outcome Measure

Single-Dose PK Parameter AUCinf of GS-4571 [ Time Frame: Up to 96 hours postdose ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Qps-Mra, Llc.MiamiFlorida33143-
ICON Early Phase Services, LLCSan AntonioTexas78232-
ICONSalt Lake CityUtah84124-

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By research site
Qps-Mra, Llc.· Miami, FLICON Early Phase Services, LLC· San Antonio, TXICON· Salt Lake City, UT

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